Breast implants have been scrutinized and scandalized ever since their inception in the 1960s, when safety data was scant and regulations were nonexistent. Medical devices, including implants, didn’t come under the purview of the U.S. Food and Drug Administration (FDA) until 1976—and the agency didn’t press breast implant manufacturers for proof of safety and efficacy until 1988.
When it became clear, in 1992, that studies were woefully lacking, the FDA placed a moratorium on the cosmetic use of silicone breast implants pending further evaluation. (Saline breast implants were exempt from the ban.)
Throughout the ’90s, million-dollar lawsuits alleging implant-induced health problems, from cancer to autoimmune ailments (like rheumatoid arthritis), bankrupted major breast implant manufacturers.
Meanwhile, evidence slowly began to emerge supporting the safety of breast implants. Several landmark papers in prestigious medical journals failed to show a link between breast implants and various diseases and disorders.
The FDA lifted the ban on silicone implants in 2006—and since then, breast augmentation has ranked among the top five surgical procedures year after year. Still, despite overwhelmingly positive study outcomes, hundreds of thousands of happy patients, and safer-than-ever implant technology, public suspicion remains.
And it’s not entirely unwarranted: In recent years, breast implants have been implicated in a rare but deadly type of immune system cancer called anaplastic large-cell lymphoma (or ALCL) as well as a more controversial (and still unproven) condition dubbed breast implant illness, or BII, which is marked by symptoms like anxiety, chronic fatigue, brain fog, and joint pain.
In response to growing concerns around breast implant safety, the FDA held a two-day meeting of the General and Plastic Surgery Devices Panel in March of 2019, to debate the potential risks of breast implants as well as the benefits. The proceedings resulted in stronger safety requirements (issued by the FDA in 2021), including a black box warning on implant labeling alerting patients to potential risks, like ALCL; a mandatory patient checklist; a revised rupture-screening protocol; and other measures designed to underscore the importance of informed consent and transparency around breast implant risks as they relate to women’s health.
While breast implants are generally considered safe, they all come with health risks and potential complications—and they do not last a lifetime. They require vigilant monitoring and eventual replacement, which means additional surgeries.
Before committing to breast implant surgery, consult with several board-certified surgeons, to find one you trust. Make sure you’re fully informed about the potential risks associated with various implant types before moving forward with your operation.
Learn more about implant safety for breast reconstruction patients.
Breast implant complications and potential risks
1) Capsular contracture
The most common complication associated with breast implants is capsular contracture, an abnormal tightening of the collagen-rich capsule—or membrane of scar tissue that naturally forms around all breast implants—which causes breasts to feel stiff and sore and look misshapen or asymmetrical.
Current data shows capsular contracture to be more common after revision breast implant surgery or in breast reconstruction patients who’ve previously had radiation treatment. It’s also a greater risk for women who have their implants placed over the muscle rather than under it.
While the exact cause of capsular contracture is unknown, doctors theorize that bacterial contamination at the time of breast implant surgery plays a role. Plastic surgeons stress the importance of adopting a multistep aseptic surgical technique in order to minimize contamination of the implant and the breast pocket.
For a closer look at who’s most prone to this breast implant complication and how surgeons treat the condition, read our complete report on capsular contracture.
2) Breast implant rupture
Implant rupture—the technical term for tears or holes that form in implants—can happen as an implant ages, or it can be the result of capsular contracture or extreme physical trauma (a car accident, for instance). In rare cases, implants have been known to rupture due to compression during a mammogram.
Reported rates of implant rupture at 10 years vary by implant type and brand, ranging from 3.9% to more than 16%.
The way a rupture is detected and managed depends on the type of implant you have.
Saline breast implant rupture
In saline-filled implants, ruptures are obvious because the breast visibly deflates over days to weeks as the saltwater is gradually absorbed by the body. The empty implant is eventually swapped out.
“Saline breast implant failures are not harmful but can be upsetting to patients, since they suddenly need to stuff their bra until the implant can be replaced,” says San Francisco plastic surgeon Dr. Karen Horton.
Silicone breast implant rupture
Silicone implant ruptures are referred to as “silent ruptures” because oftentimes, there are no obvious or immediate symptoms—and for a very good reason: modern silicone implants are made of leakproof cohesive gels that allow the implant to hold its shape if torn. On occasion, however, “patients may notice a difference in the consistency of the gel or shape of the breast,” notes St. Louis–based plastic surgeon Dr. Patricia McGuire.
While previous generations of silicone implants were known to “bleed,” or ooze silicone through their outer silicone shells, upgrades to both shell design and gel materials have curbed the incidence of bleeds. If silicone somehow manages to seep through, doctors say, it’ll likely get trapped by the scar-tissue capsule around the implant. On very rare occasions, it’s possible for the gel to escape into the breast tissue or beyond, which makes it very hard—sometimes impossible—to remove.
While silicone is an inert substance that’s been safely used in a variety of medical devices for decades, we don’t yet have complete science on how different women’s bodies react to silicone that has “migrated”; but there have been a handful of documented cases of migrated silicone causing swelling of the lymph nodes.
Updated FDA screening guidelines for silicone gel implants
The FDA recently revised its screening guidelines for silicone gel implants, updating both the type of imaging they recommend and the timetable for scans.
Previously, patients were encouraged to book MRIs three years after their initial breast implant surgery and every two years following, to check for ruptures. But surgeons have long argued that these expensive MRIs are largely impractical and not typically covered by health insurance. Unsurprisingly, only about 6% of women with silicone implants actually followed the old MRI guidance, according to new research published in the journal Plastic and Reconstructive Surgery.
High-def ultrasound, on the other hand, “is more practical, less costly, and maybe even more effective than MRI,” says Nashville, Tennessee, plastic surgeon Dr. Mary Gingrass.
The FDA now suggests having an ultrasound or MRI five to six years after silicone implants are placed and every two to three years thereafter. (With newer generation, highly cohesive gel implants, ruptures are incredibly uncommon prior to that five-year mark.) Many plastic surgeons now offer their breast implants patients routine ultrasounds right in the office.
Patients can also help catch silent ruptures by performing routine self-exams and alerting their plastic surgeon to irritation, swelling, pain, or lumps.
Ruptured silicone and saline breast implants need to be replaced or removed. All four FDA-approved implant manufacturers offer warranties that cover some portion of the cost of replacement, in the event of rupture.
Related: Silicone vs. Saline Breast Implants? 5 Things to Know About Picking the Right Type for You
3) Mammography shadows
Mammography shadows from implants can complicate the early detection of breast cancer, which affects one in eight women in the U.S.
Tell your radiology technician that you have breast implants and make sure she is experienced in doing X-rays of implanted breasts. Follow your surgeon’s recommendations for ultrasounds or MRIs.
4) Implant rippling or creasing
Ripples or creases can happen if:
- The capsule of tissue covering an implant sticks to its surface.
- The implant pocket is too big, allowing the device to shift.
- The implant itself develops folds, which can become visible through thin breast tissue.
Saline breast implants—particularly if they’re underfilled or deflated—are more prone to wrinkling than silicone types. And textured breast implants tend to ripple more than smooth. These abnormalities are most visible in slender women without much natural breast tissue.
While some surgeons find that having thin patients gain a few pounds can sometimes solve the problem nonsurgically, the go-to fix for ripples is revision surgery, usually incorporating fat grafting and/or an acellular dermal matrix (ADM), which is a synthetic mesh that provides support and prevents sticking.
The FDA is currently evaluating but has not approved the use of mesh in breast augmentation and reconstruction.
5) Breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL)
Breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma found in the scar tissue and fluid surrounding an implant, is an uncommon but serious complication associated with both silicone and saline devices with textured surfaces. The FDA identified a possible link between breast implants and ALCL in 2011, and the World Health Organization confirmed it in 2016.
Per the most up-to-date American Society of Plastic Surgeons (ASPS) data, “the current lifetime risk of BIA-ALCL is estimated to be 1:2,207–1:86,029, based upon variable risk with different manufacturer types of textured breast implants. Since the initial case report in 1997, ASPS now recognizes approximately 389 both suspected and confirmed cases in the U.S. and a total of 1,216 worldwide as of June 2022.”
It’s worth noting, some patient advocates insist that BIA-ALCL is underdiagnosed.
How is BIA-ALCL diagnosed?
BIA-ALCL typically presents as persistent pain and/or swelling near the implant, due to fluid accumulation. Diagnosis entails a biopsy or sampling of fluid from the breast, which is then sent to a lab for analysis. The disease can take 8 to 10 years to develop.
How is BIA-ALCL treated?
In its early stages, removing both the implant and its surrounding capsule of tissue (a capsulectomy) has been shown to completely cure women of this cancer. In cases where the cancer has spread to lymph nodes or other tissues, patients have also required chemotherapy and radiation.
Which implants are linked to BIA-ALCL?
Dr. McGuire tells us that “all the cases of BIA-ALCL where the full implant history was known involved a textured surface implant. There has never been a verified case where a patient had only smooth implants.”
At the FDA hearing, researchers testified that heavily textured implants with greater surface area are more prone to the bacterial colonization that precipitates the inflammatory response thought to trigger BIA-ALCL. Allergan’s Biocell implant—with the most aggressive macrotexture surface—has been implicated in approximately 85% of confirmed BIA-ALCL cases.
The FDA requested that Allergan recall its Biocell breast implants and tissue expanders from the global market in July 2019. Allergan complied, issuing a worldwide recall of its Biocell textured products, including its Natrelle silicone- and saline-filled implants, Natrelle Inspira implants, Natrelle 410 implants, and Natrelle tissue expanders.
At this time, the FDA has not recommended the removal or replacement of recalled implants in asymptomatic patients, but anyone who has reason to believe their textured breast implants are causing an issue should consult a plastic surgeon.
The case for textured breast implants
While more than 90% of implants used in the U.S. are smooth, some American plastic surgeons still use textured implants in select cases, claiming they offer unique advantages over their smooth-shelled counterparts. All anatomic or teardrop implants are textured, and many providers rely on these devices to provide shape to women who have very little breast tissue to start with and to correct asymmetries and congenital abnormalities (like tuberous breasts).
“I stopped using textured implants in 2016, as the number of ALCL cases continued to increase,” says Dr. McGuire. “Up until that time, shaped implants were my preference in breast reconstruction, because they gave great upper-pole fullness. Really though, the implant is only one factor in the result of a reconstruction, and a good, natural outcome can be obtained with any implant.”
6) Breast implant illness (BII)
A hot topic at the FDA hearing in March 2019, BII is a term used to describe a spectrum of symptoms that some women attribute to their breast implants. Common complaints include brain fog, chronic fatigue, joint pain, anxiety, hair loss, body odor, and sleep disturbances, among others.
Is breast implant illness real?
This is a huge point of contention in the plastic surgery community. At present, BII is not a medically recognized disease, since doctors don’t yet have enough evidence to prove or disprove its existence. Moreover, “unlike with BIA-ALCL, there is no test to diagnose BII,” explains Nashville, Tennessee, board-certified plastic surgeon Dr. Melinda Haws. “The best we can do is to exclude other causes and see if symptoms improve after implant removal.”
Dr. Haws, who heads up The Aesthetic Society’s BII task force, has implants herself. And despite the unrelenting controversy in this realm, she says, “I would still recommend breast implants to my mom if she gets breast cancer and needs reconstruction. I would still support my daughter, once she’s old enough, in getting breast implants if she wanted them.” However, she adds, “I’ve also treated several very rational, reasonable, and intelligent women who believe they have breast implant illness. I take their implants out, and many of them do feel better.”
New research into BII
ASERF, the research arm of The Aesthetic Society, is currently studying BII and breast implant safety. Much of the research focuses on breast implant capsules (the scar tissue that forms around the implant), since there is great debate among patients and providers concerning the role capsules play in BII and the questionable need to remove them along with the implants to help patients heal.
Women with BII commonly request an “en bloc” capsulectomy—removing the implant and its intact capsule as a single unit—believing this to be the only cure for BII. Since en bloc removal can be risky and involves large scars, surgeons are generally hesitant to perform the procedure barring an ALCL diagnosis, where they must keep the malignant cells contained.
In a pivotal BII study, funded by ASERF and published in the Aesthetic Surgery Journal in 2022, researchers followed three groups of women undergoing breast surgery: those with BII symptoms who were having their implants removed; women having their implants taken out or exchanged for reasons other than BII; and, as a control group, breast lift patients who had never had implants. Blood and capsules were collected from the first two groups; blood only was taken from the control group.
Ultimately, 96% of subjects with BII reported at least a partial improvement in their symptoms after explanting—and the improvement lasted for at least six months.
An equally compelling finding: The specific type of capsulectomy performed—intact total (aka en bloc), total, or partial—had absolutely no bearing on the degree of symptom resolution.
Part two of this study analyzed the subjects’ capsules and blood samples for heavy metals (which BII patients often cite as a potential contributor to symptoms). Since certain metals were detected in all three cohorts, including the implant-free control group, the authors concluded, “The risk of heavy metal toxicity should not be used as an indication for a total capsulectomy if patients elect to remove their breast implants.”
How common is breast implant illness?
Given that BII is a self-reported condition, we can’t cite a reliable incidence or case count. There are, however, dozens of BII support groups across social media—some with six-figure memberships—so it’s certainly not an uncommon concern.
What we do know is that BII seems to be more prevalent among implant patients with preexisting immune system disorders. Dr. Allen Gabriel, a plastic surgeon in Vancouver, Washington, finds that “patients with a personal or family history of autoimmune disease will probably have a more aggressive reaction toward any foreign body implanted in their body, so they should know they’re at higher risk for reactions.”
Indeed, the FDA acknowledged this fact in a statement on medical device safety, noting that “a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”
Should you have your breast implants removed?
If you’re experiencing symptoms associated with breast implant illness and are considering implant removal, it’s a good idea to consult with more than one board-certified plastic surgeon.
Be wary of providers pushing en bloc procedures, which are not indicated for BII and can be dangerous. RealSelf has received reports that some doctors are charging exorbitant fees for en bloc implant removal and additional surgeries or treatments that can lead to serious complications (including punctured or collapsed lungs) and disfigurement.
Before having your implants removed, talk to your surgeon about how your breast tissues might respond to surgery—and what additional surgical procedures they might recommend to give you the best implant-free outcome. Oftentimes, the breasts can appear deflated, droopy, or otherwise deformed following explant, but fat grafting or a breast lift can help recreate a more beautiful, natural appearance.
The bottom line on the safety of breast implants
According to the most recent stats from the International Society of Aesthetic Plastic Surgery, more than 1.6 million women worldwide had breast augmentation surgery in 2021. So we think it’s fair to say that breast implant safety is a women’s health issue.
The FDA continues to work in partnership with the plastic surgery industry to boost transparency around the risks of breast implants, to make long-term study data available to the public, to empower every patient to make a truly informed decision, and to hold breast implant manufacturers accountable for their products and promises.
While we now know which types of implants are more likely to cause health problems (i.e., those with heavily textured shells), there really isn’t a clear consensus on which implants are the safest. Your best bet is to choose an experienced, board-certified plastic surgeon to guide you through the process of selecting the most appropriate, safest implant—for you.
